Market overview Japan is the second largest market for medical devices in the world after the USA. This may be because all Japanese citizens are covered by national health insurance and Japanese medical device regulations are harmonised internationally1. Therefore, Japanese…
In this first ‘Peer to Peer Learning’ article, Olivia Lee, a Regulatory Affairs Specialist from Aevice Health, shares her experiences of a small start-up company working with the US FDA to obtain 510(k) clearance. In the fast-paced environment of…
Introduction The UK continues to build its position as a sovereign nation, seeking to be a global leader. The medical technology and in vitro diagnostic (IVD) industries may not be on everyone’s radar, but they are critical, underpinning industries of…
